1. Field of the Invention
The present invention relates to a stopper device for a container in which a passage for access to the interior of container can be easily formed in a state in which the stopper device is fitted to a container. More particularly, the present invention relates to a stopper device for container used, for example, in medical treatment, which enables easy formation of a passage therein With a connecting device having no edge at the front end and which requires, for passage formation, no hollow tube having an edge at the front end (e.g. spike needle, injection needle).
The present invention further relates to a mixing apparatus using the above stopper device, for example, a container for transfusion suitably used in instillation.
2. Description of the Prior Art
There are various types of stopper devices for container. A rubber stopper is often used when it is required to take out contents from a container or to inject a certain material into the container, for example, when a drug solution for medical treatment is prepared by mixing or is transferred, because the rubber stopper can provide a simple and effective means for shielding the contents from the air. In this case, the perforation of the rubber stopper has been conducted by stabbing the rubber stopper with a hollow connecting device having an edge at one end such as spike needle, injection needle or the like. In the field of medical treatment, in particular, a rubber stopper is widely used as a stopper device for containers. The rubber stopper is used also as a stopper device for a container for transfusion. Ordinarily, the spike needle of a transfusion device is inserted into the rubber stopper fitted to a container for transfusion and the drug solution contained in the container is administered to a patient through the transfusion device. Since this spike needle is a hollow needle having an edge at one end, part of the rubber stopper is cut off by the edge and mixed with the drug solution in the container; this has invited the generation of a foreign matter in the drug solution, i.e. the generation of a foreign matter by coring. A thick spike needle is used when transfusion must be made at a high rate; in such a case, part of the rubber stopper is easily cut off and the generation of a foreign matter is easily invited.
A powdery drug such as antibiotic or anticancer drug, or a freeze-dried drug is contained in a container such as vial or the like and then sealed with a rubber stopper. Such a powdery drug or a freeze-dried drug is dissolved in a dissolving agent before being administered to a patient. In this case, the container containing the above drug and the container containing the dissolving agent are connected by using a connecting device such as double-ended needle, connecting tube having a spike needle or the like at one end, and then the dissolving agent is transferred into the container containing the drug to dissolve the drug. The connection of the two containers with the double-ended-needle or the connecting tube is conducted by stabbing the respective rubber stoppers of the two containers with the double-ended needle or the spike needle of the connecting tube; as a result, it has invited the introduction of foreign matter from coring as well. In order to-conduct the transfer of the dissolving agent swiftly, it is necessary to use a double-ended needle or a spike needle, each having a large inside diameter. The use of such a needle having a large inside diameter, however, requires a large force for puncturing and makes the connection of the two containers difficult and further invites the generation of debris from coring and possibly the blocking of the through-hole of the double-ended needle or spike needle with part of the rubber chips generated.
The rubber stopper which is generally used as a stopper device for containers, provides a convenient sealing means. However, it has problems, for example, (a) the formation of a passage therein is not easy (more so when the thickness of the rubber stopper is large), (b) chips are generated by coring and (c) the reliable formation of a passage of relatively large diameter is very difficult and, accordingly, the rate of solution transfer through the passage has an upper limit.
The operation of connecting a container containing a drug and a container containing a dissolving agent for the drug is widely carried out in medical institutions such as hospitals and the like. This operation is complex and time-consuming and moreover may invite the leakage of the dissolving agent and the contamination of the drug because the operation involves puncturing of the rubber stoppers fitted to the two containers.
In order to avoid such operational complexity and risks of leakage and contamination, there have been made attempts to combine the drug container and the dissolving agent container into one apparatus.
As such an apparatus, Japanese Patent National Publication of Translated Version No. 501129/1986 (International Publication No. WO85/03432) proposes a container for transfusion. This container for transfusion comprises (a) a capsule accommodating a vial as a drug container, (b) a flexible container containing a dissolving agent and having a solution outlet, and (c) a tube connecting the capsule (a) and the flexible container (b). To the tube are fitted a hollow spike needle at the vial side and a breakable member at the flexible container side. The breakable member blocks the passage of the tube and prevents the passing of liquid through the passage.
In actual use of the above container for transfusion, the vial in the capsule is depressed and thereby the rubber stopper of the vial is punctured with the spike needle to connect the vial with the flexible container; then, the breakable member in the tube is manually bent to break it to clear the passage of the tube; thus, the drug and the dissolving agent can be mixed.
The container for transfusion proposed in Japanese Patent National Publication of Translated Version No. 501129/1986 is improved in that the mixing of the drug and the dissolving agent is conducted by connecting the respective containers. However, the container for transfusion has problems in that its operation is still considerably time-consuming because the rubber stopper of the vial must be punctured with the spike needle and then the breakable member is manually bent to clear the passage of the tube and also in that the incomplete bending of the breakable member reduces the flow rate of liquid and requires a longer time for dissolution.
Japanese Patent Application Laid-Open No. 1277/1990 proposes a further improved container for transfusion comprising (1) a flexible container containing a dissolving agent or a diluent and having a liquid passage having an isolator at the upper end, (2) a capsule connected to the flexible container, (3) a drug container sealed with a puncturable stopper at the mouth, held inside the capsule (2), and (4) a communication means for allowing the interiors of the flexible container and the drug container to communicate with each other. The communication means comprises (a) a hollow spike needle having a hub at the middle and each one edge at the two ends and (b) a communication sequence-controlling means to carry out communication in such a sequence that the stopper of the drug container is perforated with one edge of the spike needle and then the isolator of the flexible container is perforated with the other edge.
The container for transfusion proposed in Japanese Patent Application Laid Open No. 1277/1990 is improved in that the mixing of the drug and the dissolving agent is conducted by connecting the drug container and the dissolving agent container and further in that the operation is slightly simplified. In this container for transfusion, however, since a hollow spike needle is used as a communication means for the drug container and the dissolving agent container as in the container for transfusion proposed in Japanese Patent National Publication of Translated Version No. 501129/1986, the edge of the spike needle cuts off part of the stopper fitted to the drug container when the stopper is perforated with the edge, and the resulting debris enter the drug to become foreign matter. That is, in the above container for transfusion, there have arised the generation of foreign matter from coring and the blocking of the through-hole of the tube with part of the debris. The stopper for a drug container, in particular, is thick in order to prevent the quality change of the drug contained in the drug container and therefore tends to invite the generation of debris from coring and the blocking of the through-hole of the spike needle with part of the debris. On the other hand, the use of a hollow spike needle of small inside diameter as a communication means in order to reduce the generation of debris from coring, requires a longer time for mixing of the drug and the dissolving agent.